Clinovo hosted a truly informative panel discussion on the topic of adaptive clinical trials in Palo Alto,CA on November 2. It was a great forum to hear some very experienced clinical trial professionals share their experiences with a standing-room-only audience. In addition, it was a friendly environment to network with Bay Area colleagues before and after the panel discussion. The event was impressive enough to make me want to embark on my first visit to the blogosphere. Here goes…
During the panel session, the first thing that struck me was when the panelists explained that while the phrase “adaptive clinical trial” is a somewhat new bit of bio-pharma jargon, we all have been running trials for decades that fit this moniker – we just didn’t know it. It is also clear that these trials are increasing in number, and are helping to save millions for the biopharmaceutical industry.
From the FDA’s Draft Guidance: Adaptive Design Clinical Trials for Drugs and Biologics – February 2010
(Page 6) Definition and Concept of an Adaptive Design Clinical Trial
For the purposes of this guidance, an adaptive design clinical study is defined as a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study.
Analyses of the accumulating study data are performed at prospectively planned timepoints within the study, can be performed in a fully blinded manner or in an unblinded manner, and can occur with or without formal statistical hypothesis testing.
As a member of the eClinical community myself, I was also pleased to hear a common theme throughout the discussion, which was how great an impact technology was making on the ability to achieve the goals of adaptive trials. All of the panelists explained how EDC made it possible to have access to their data in a way that facilitated the type of decisions critical to adaptive studies. It was clear that ‘in the old days with paper’, it was very difficult, or impossible to make the type of mid-stream analysis and decisions which we now take for granted.
I was pleased to hear Oranee Daniels from Theravance mention that she could look at her ePRO data every morning if needed, and always know that she was looking at the most up-to-date information for making the crucial decisions associated with the adaptive design.
Don Kellerman from Map Pharmaceuticals also explained his experience with killing studies by determining futility through adaptive trial design. Don had a great sense of humor; he warned about giving him a compound to evaluate, since he has a proven track record for quickly finding futility.
All in all, I felt the event was a great success. I would certainly attend future sessions of the Silicon Valley BioTalk series. Kudos to Clinovo for putting it together and generating the interest for such a great turn out on a Wednesday evening. It attracted participants from all over the Bay Area, and beyond.
Director, Business Development, CRF Health